Evaluating Behavioral Treatments to Improve Adherence to Continuous Positive Airway Pressure (CPAP) Therapy in People With Obstructive Sleep Apnea (The BREATHE Study) (BREATHE)
|ClinicalTrials.gov Identifier: NCT00623246|
Recruitment Status : Completed
First Posted : February 25, 2008
Last Update Posted : September 29, 2016
|Condition or disease||Intervention/treatment||Phase|
|Sleep Apnea, Obstructive Continuous Positive Airway Pressure||Behavioral: MET Behavioral: ED||Not Applicable|
OSA is a common sleep disorder that is characterized by a brief collapse and blockage of the upper airway during sleep. This blockage prevents air from flowing properly into the lungs and causes pauses in breathing. Symptoms include loud snoring, choking or gasping during sleep, and abnormal daytime sleepiness. If left untreated, OSA can lead to heart disease, high blood pressure, and stroke. The most common treatment for OSA is CPAP therapy, in which a mask is worn over the nose during sleep and pressurized air flows through the mask to keep the throat open. Unfortunately, CPAP treatment adherence is often poor. Previous research studies showed that people receiving motivational enhancement therapy (MET) or educational therapy (ED) adhered better to CPAP treatment than did people not receiving MET or ED therapy. However, even for people who received MET or ED, adherence usually diminished after 12 months. It appears that patterns of treatment adherence are often set early and people who maintain adherence within the first week of treatment have a greater chance of maintaining long-term adherence. Using enhanced, more intense versions of MET and ED that are delivered when CPAP therapy begins, this study will evaluate the effectiveness of MET and ED at improving CPAP treatment adherence in people with OSA.
This study will enroll people with OSA. Participants will be randomly assigned to a 12-week MET group, a 12-week ED group, or a standard clinical care group, with all treatments beginning at the time participants start CPAP therapy. All participants will attend a baseline study visit to undergo weight and blood pressure measurements; assessments of cognitive functioning, mood, daytime sleepiness, functional outcomes, and attitudes toward therapy; and an optional blood collection. At baseline and Week 1, participants in the MET and ED groups will take part in two 45-minute, face-to-face counseling sessions. During these sessions, participants in the MET group will receive motivational counseling from study staff, and participants in the ED group will receive educational information about OSA from study staff. At Months 1 and 3, participants will receive two phone calls from study staff. The MET group will receive motivational counseling during these calls, with a focus on building self-efficacy and providing personalized feedback on health and adherence patterns. The ED group will receive educational information and feedback on problem-solving and adherence during the calls. Throughout the study, all participants will have their CPAP adherence electronically monitored on a daily basis. Participants who fail to meet the minimum standard of CPAP adherence will receive up to four additional phone calls during the study. At Months 3, 6, and 12, all participants will attend study visits for repeat baseline measurements.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||306 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Motivating Adherence to CPAP in Obstructive Sleep Apnea|
|Study Start Date :||December 2007|
|Actual Primary Completion Date :||November 2012|
|Actual Study Completion Date :||November 2015|
Active Comparator: 1
Participants will receive motivational enhancement therapy (MET) for 12 weeks.
MET will involve motivational counseling sessions and phone calls, with a focus on building self-efficacy and providing personalized feedback on health and adherence patterns based on CPAP adherence monitoring.
Active Comparator: 2
Participants will receive educational therapy (ED) for 12 weeks.
ED will involve sessions and phone calls that include educational information, problem-solving, and adherence feedback from study staff.
No Intervention: 3
Participants will receive standard clinical care.
- Adherence to CPAP [ Time Frame: Measured at Months 3, 6, and 12 ]
- Cognitive function [ Time Frame: Measured at Months 3, 6, and 12 ]
- Subjective sleepiness [ Time Frame: Measured at Months 3, 6, and 12 ]
- Quality of life [ Time Frame: Measured at Months 3, 6, and 12 ]
- Blood pressure [ Time Frame: Measured at Months 3, 6, and 12 ]
- Cytokines and inflammatory markers [ Time Frame: Measured at Month 3 ]
- Attitudes toward CPAP use (transtheoretical model [TTM] and social cognitive theory [SCT] model variables) [ Time Frame: Measured at Months 3, 6, and 12 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00623246
|United States, Colorado|
|National Jewish Medical and Research Center|
|Denver, Colorado, United States, 80206|
|Principal Investigator:||Mark S. Aloia, PhD||National Jewish Health|